UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of coffee chlorogenic acid in grade I hypertension and high-normal blood pressure on blood pressure: a meta-analysis using individual participant data
Title of the study (Brief title)	A individual participant data meta-analysis of coffee chlorogenic acid.
Region	Japan

Condition
Condition	in grade I hypertension and high-normal blood pressure
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This individual participant data (IPD) meta-analysis was to assess the overall effect of coffee chlorogenic acid supplementation on grade 1 hypertension and high-normal blood pressure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood pressure (systolic blood pressure and diastolic blood pressure)
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Randomized controlled trials. Participant: Grade I hypertension and/or high-normal blood pressure without treatments. Intervention: Ingestion of coffee chlorogenic acid for 12 or more weeks. Comparison: Placebo. Outcome: Blood pressure.
Key exclusion criteria	Studies, which do not meet Key inclusion criteria were exclude
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuya Kozuma
Organization	Kao Corporation
Division name	Health Care Food Research lab
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	03-563-7476
Email	kouzuma.kazuya@kao.com

Public contact
Name of contact person	Kazuya Kozuma
Organization	Kao Corporation
Division name	Health Care Food Research Labs.
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	03-563-7476
Homepage URL
Email	kouzuma.kazuya@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 04 Month 25 Day
Anticipated trial start date	2018 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Kozuma et al. Effect of coffee chlorogenic acid in grade I hypertension and high-normal blood pressure Japanese adults on blood pressure: a meta-analysis using individual participant data from randomized controlled trials. Jpn Pharmacol Ther. 2018; 46: 1157-1166
Other related information	Data sources Medline (PubMed), JDream3 and University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR)

Management information
Registered date	2018 Year 05 Month 09 Day
Last modified on	2018 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037094